About this trial
Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis. Despite improved procedural outcomes, neurocognitive complications such as postoperative delirium (POD) and postoperative cognitive decline (POCD) remain clinically relevant.
Heart Valve Units (HVU) are specialized interdisciplinary care structures designed to improve treatment pathways and healthcare quality. However, their impact on neuropsychological outcomes has not been sufficiently investigated.
HVU-NEURO is a prospective observational cohort study evaluating neuropsychological outcomes before and after implementation of an HVU. Approximately 500 patients undergoing transcatheter valve therapy will be included.
Neurocognitive function will be assessed before intervention, at hospital discharge, and three months after intervention. POD will be assessed using the Intensive Care Delirium Screening Checklist (ICDSC). The primary objective is to evaluate the effect of HVU implementation on postoperative cognitive decline at discharge from acute hospital care.
Eligibility criteria
Qualifiers
Severe aortic valve stenosis
Indication for transcatheter valve therapy according to current guideline recommendations and/or Heart-Team consensus
Sufficient German language proficiency, as study-related tests, questionnaires, and instructions are administered in German
Age ≥18 years
Disqualifiers
Known pregnancy at the time of study inclusion
Life expectancy <1 year due to non-cardiac disease
Pre-interventional psychiatric and neurological disorders (known and diagnosed dementia, depression, history of stroke or transient ischemic attack [TIA], migraine, epilepsy) with acute symptoms that may interfere with data collection
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Locations
Sponsors and collaborators
Heart and Brain Research Group, Germany
Lead sponsor
University of Giessen
Collaborator
University Hospital Giessen and Marburg
Collaborator
Kerckhoff Klinik
Collaborator